Recruiting

PrEP Integration

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07292792

Conditions

HIV Disease

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Health Coach Intervention

Study Details

Brief summary:

This 18-month study, "Integration of peer health navigation into comprehensive re-entry services: improving PrEP implementation for justice-involved individuals," aims to increase PrEP awareness and uptake among people with a history of justice involvement in Dallas, primarily clients of Unlocking Doors.

Conditions

HIV Disease

HIV Prevention

Study ID

NCT07292792

Start date

May 21, 2025

Status verified date

Jan, 2026

Completion date

Nov 21, 2026

Anticipated

Primary completion date

Nov 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 years or older
2. Client of Unlocking Doors
3. Able to provide informed consent
4. Willing to participate in discussions about general health, sexual health, HIV prevention, and PrEP
5. Willing to complete health screening and eligibility assessment
6. For qualitative interview participants:

  • Unlocking Doors staff, clients, or PrEP providers who agree to participate in a one-time interview.

Exclusion Criteria:

1. Under 18 years of age
2. Unable to provide informed consent
3. Not receiving services at Unlocking Doors
4. Non-English speakers
5. Diagnosed with HIV
6. Incarcerated individuals at the time of recruitment

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Health Coach Intervention Group

Participants in this group are clients of Unlocking Doors who meet eligibility criteria and choose to enroll in the study. They receive the health coach intervention, which includes general health and sexual health discussions, HIV and syphilis testing, PrEP education, PrEP eligibility screening, linkage to PrEP care, and referrals to other health or re-entry services. Their PrEP knowledge, interest, and engagement, as well as feasibility and acceptability of the model, are assessed throughout the study.

Interventions

Health Coach Intervention

The intervention integrates a PrEP-focused health coach into Unlocking Doors' re-entry services. The health coach provides clients with general health guidance, sexual health education, HIV and syphilis testing, PrEP education, PrEP eligibility screening, and linkage to PrEP care. The coach also offers ongoing navigation and referrals to medical, behavioral health, and re-entry services as needed. The aim of the intervention is to increase PrEP awareness, interest, and uptake among justice-involved individuals while assessing feasibility, acceptability, and appropriateness of embedding a health coach within legal re-entry services.

Primary outcome measure

  • Feasibility of Integrating a PrEP-Focused Health Coach [ Time Frame: 18 Months ]
  • Acceptability of the Health Coach Model [ Time Frame: 18 Months ]
  • Appropriateness of the Health Coach Model [ Time Frame: 18 Months ]

Central Contacts and Locations

Central contacts

Laura A Hansen, MA

7133057882Laura.Hansen@UTSouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-15.